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Risk assessment tool for novel applications


ESHRE Contributors and their positions at the time:
Cristina Magli, Italy, ESHRE Chair
Kelly Tilleman, Belgium, ESHRE SIG Safety and Quality in ART
Anna Veiga, Spain, former ESHRE Chair
Nathalie Vermeulen, Belgium, ESHRE Research Specialist

Good Tissue and cell Practice (Euro-GTP II)

This project aimed to establish good practices with regard to Tissues and Cells with a special focus on the risk assessment associated to the introduction of novel tissue / cell applications.
The project had three goals: 1) to set up good practices governing tissue and cell preparation processes, and patient follow-up procedures in a safe and effective manner. This is pursued through development of methodologies that assess the risks associated with the novel tissue/cell applications and by follow up programs that ensure safety and support the evaluation of the clinical efficacy. 2) to develop a database of products, preparation procedures, clinical applications and follow-up programs, and their current status of authorization and implementation. 3) to propose a GTP’s Management Model foreseeing future update, promotion and harmonization of GTP’s standards, and the implementation of accreditation and training programs at the European level.

Working Package 8 was dedicated to "Good practices for demonstrating safety & quality through recipient follow-up in ART". The expected outcome was to provide an interactive tool that makes it possible to classify ART treatments and procedures through laboratory KPIs and recipients’ follow up.

The outcomes from the project were available for open consultation until 21st December 2018.

You can now find the EuroGTP II guide at the following link http://www.goodtissuepractices.site/docs/EuroGTP_II_Guide.pdf, and the interactive tool at http://tool.goodtissuepractices.site/ that permits to assess the risk associated to novel tissue or cell applications. The corresponding results are reported on a database http://db.goodtissuepractices.site/ that provides a compendium of tissue and cells therapies and products that have proven to be safe and efficacious for the associated indication.
ESHRE also participated in the dissemination events aimed at spreading the outcomes of EuroGTP II.

ESHRE has been an active stakeholder of the EuroGTP2 project from the beginning.


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